The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 300 μg

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Drug: Placebo

Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Experimental: Placebo followed by indacaterol 300 μg

Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 300 μg

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Drug: Placebo

Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period [ Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9) ]

At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.

Secondary Outcome Measures :

Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose [ Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9) ]

At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

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Ages Eligible for Study:

40 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.

Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and: